- Daiichi Sankyo, Inc. (Bernards, NJ)
- …matters; Represents Clinical Development in Project Teams, possibly as Global Clinical Lead . ResponsibilitiesStudy Strategy: Clinical study leader (CSL) ... and geographic scope. Such trials could be pivotal for submission; Prepares clinical section of regulatory documents; Oversees management and performance of CRO;… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …matters; Represents Clinical Development in Project Teams, possibly as Global Clinical Lead . Responsibilities:Study Strategy: Clinical study leader (CSL) ... and geographic scope. Such trials could be pivotal for submission; Prepares clinical section of regulatory documents; Oversees management and performance of CRO;… more
- Merck & Co. (Boston, MA)
- Job DescriptionThe Executive Clinical Director (Distinguished Scientist) has primary responsibility for the strategic planning and directing clinical research ... compounds in Immunology. With a focus on late-stage development, the Executive Clinical Director will manage the entire cycle of clinical development,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …employer including veterans and people with disabilities. SummaryThis position will be the Clinical Science Group Lead in late phase development in the Global ... the Senior Director level for each respective program. This Clinical Science (CS) Group Lead will be responsible for overseeing multiple program-level CS Asset… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of Clinical Pharmacology and Modeling and Simulation plans, design and lead study teams to execute Clinical Pharmacology studies, conduct hands on ... for all aspects of clinical pharmacology and biopharmaceutics studies; clinical pharmacology project lead ; supports Phase 2/3 clinical … more
- Merck & Co. (North Wales, PA)
- …including those new to the organization therefore requiring someone who has built and lead clinical development plans from the ground up. They will also be ... Job DescriptionThe Associate Vice President (AVP)/Section Head, Global Clinical Development, Ophthalmology will focus on driving strategy, development, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of clinical supplies across the DSI portfolio. This role as CSO ( Clinical Supply Planning and Operations) Project Lead is primarily responsible for ... rare diseases and immune disorders. Summary NOTE: This Project Lead Role is an Individual Contributor and sits at...service providers and working with internal departments to progress clinical supply projects. Every effort has been made to… more
- Insmed Incorporated (San Diego, CA)
- …Medical Director of Ophthalmology, Clinical Development holds the responsibility to lead clinical programs across different diseases and supervising the ... trials, through to full development.Serve as the therapeutic area lead of the ophthalmology clinical development team,...the therapeutic area lead of the ophthalmology clinical development team, partnering closely with heads of … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …setting, to drive the development of potential products and drug candidates. The Manager, Clinical Pharmacology will support or take the lead on generation of ... clinical development. ResponsibilitiesServe as QCP representative on Clinical studies or take a lead on...representative on Clinical studies or take a lead on Clinical pharmacology studiesServe as QCP… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …needed- Clinical Development Expertise Strategy- In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development and execution of ... development and updates of the Investigator's Brochure (IB): author the clinical section and lead the development of the other sections in collaboration with the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …when needed Clinical Development Expertise Strategy:In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development and execution ... development and updates of the Investigator's Brochure (IB): author the clinical section and lead the development of the other sections in collaboration with the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Leaders/National Expert Panels for select clinical trials, in collaboration with Clinical Director and Clinical Operations lead Support investigator ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...on insights from the marketplace. This role may also lead the Core Medical Team, Project Team (co-chair), and… more
- Merck & Co. (Rahway, NJ)
- …Center in Rahway is looking for an Associate Director - Process Engineer to lead clinical supply manufacturing, scientific rigor of processes, and ultimately to ... is a multi-modality (small molecule, biologics, vaccine) Drug Product development and clinical manufacturing facility in Rahway, New Jersey.- This team works with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Team. In addition, he or she will interact with the Companion Diagnostics Lead , Non- Clinical Research, Medical Affairs and other stakeholders to support the ... enumerate key translational hypothesis that will drive scientific decision-making both from non- clinical and clinical translational aspects. In doing so, he or… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …input and prioritization rankings via presentation of Forecasts/Assumptions/NPVs and comparative Clinical value where possible. Lead BSA Forecasting team members ... 3 Year Rolling Forecast. The position will be the Lead on behalf of the Business Strategy and Analytics...ensure implications are assessed and communicated on timely manner- Clinical Development Life Cycle Management Decision Support: Be the… more
- Rakuten Medical Inc. - US (San Diego, CA)
- …quality, process improvement, regulatory inspection management and at least two years of clinical auditing experience as lead auditor. The candidate will have an ... of GCP Quality activities to support companywide and clinical development/ clinical trial Quality activities. Successfully lead global and cross-functional… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. ... documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to Clinical … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. Summary Provide support for all aspects of Global Clinical Operations with a high degree of quality in the execution of all ... and Medical Access/Expanded Access (MAP)/(EAP)activities in adherence to Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and… more
- Merck & Co. (Minneapolis, MN)
- …for this hybrid position will have responsibilities as both an Institutional Account Lead (IAL) and Payer Account Executive within the assigned geography and for ... limited to the following: The IAL Hybrid Institutional Account Lead / Payer Account Executive will manage the business...account performance to optimize net sales for our Company Clinical : Communicate to customers the clinical value… more
- Merck & Co. (Rahway, NJ)
- …core teamsRemain current in relevant worldwide regulatory guidance and standards. Lead /support/oversee clinical supplies production with respect to device ... strategic direction on the company's highest complexity programs they are selected lead to ensure high quality products and robust manufacturing processes.-- This… more
